Safety of the PET-511BTM Transesophageal Transducer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Brief Summary

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The purpose of this study is to demonstrate the safety of the redesigned transesophageal echocardiogram (TEE) transducer as it is inserted and transitioned into the esophagus through the mouth.

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Detailed Description

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The PET-511BTM is a multiplane transesophageal transducer designed for use with Toshiba Diagnostic Ultrasound Systems for the visualization of the heart (and other organs) as a real-time ultrasound image. It is inserted into the esophagus through the mouth to visualize a plane of the heart through the esophageal wall.

The objective of the study is to demonstrate the safe use of the redesigned Toshibal TEE transducer for ease of passage and during transitioning into and down the esophagus to complete a normal TEE study.

Conditions

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Patient Requiring TEE Procedure by Their Physician

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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TEE Procedure

Patients who have been scheduled for a TEE procedure by their physician

PET-511BTM

Intervention Type DEVICE

Transesophageal Transducer

Interventions

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PET-511BTM

Transesophageal Transducer

Intervention Type DEVICE

Other Intervention Names

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TEE Transducer TEE Probe

Eligibility Criteria

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Inclusion Criteria

* Male and female patients between the ages of 20 and 80
* Informed consent understood and signed
* Compliance with post-treatment follow-up protocol requirements